Nucleonics Cleared to Begin Phase I Testing of Hep B Drug
Nucleonics said this week that it has received clearance from US regulators to begin phase I testing of an expressed RNAi treatment for hepatitis B.
The company said it expects the clinical trial to begin in June.
As reported by RNAi News last year, that National Institutes of Health’s Recombinant DNA Advisory Committee had expressed a number of concerns about how Nucleonics has designed the proposed phase I trial for the hepatitis B drug, called NucB 1000 (see RNAi News, 12/21/2006).
However, the committee has no authority beyond making comments and recommendations, and it appears that any concerns the US Food and Drug Administration had about the planned clinical study were sufficiently addressed by Nucleonics.
“We are very pleased to be able to move forward with this human safety study, which will be the first systemic delivery of an RNAi therapeutic to patients," Robert Towarnicki, president and CEO of Nucleonics, said in a statement.
NucB 1000 is a plasmid DNA encoding four short hairpin RNA molecules, each under the control of an RNA polymerase III promoter, according to Nucleonics.
“Each of the four shRNAs targets a different segment of the HBV genome and collectively they mediate the destruction of all the different RNA molecules produced by HBV within an infected cell,” the company said.
CytRx Provides Subsidiary with $15M Contribution
CytRx said this week that it has contributed $15 million to its pure-play RNAi drugs subsidiary, RXi Pharmaceuticals (see RNAi News, 1/11/2007).
The funding satisfies RXi’s initial funding requirements under various licensing agreements with the University of Massachusetts Medical School, CytRx said, adding that RXi is required to provide the institute $275,000 in cash and $2.4 million worth of common stock.
In conjunction with the financing, CytRx also said its stake in RXi has increased to almost 90 percent. CytRx has agreed to reduce its stake to less than a majority in the form of a dividend to its shareholders.
Inex Spins Out Assets into Tekmira
Inex Pharmaceuticals said this week that it has completed the spin out of all its assets into a new company called Tekmira Pharmaceuticals.
Immediately before the spin out, Inex said its common shares were consolidated on the basis of two current common shares for one new common share. Its shareholders will own all of the new common shares of Tekmira and 20 percent of Inex’s equity.
Inex said it will be seeking new opportunities outside the pharmaceutical industry under new management.
Inex, now Tekmira, is engaged in a legal dispute with one-time subsidiary Protiva Biotherapeutics over the rights to a delivery technology for RNAi. As part of that dispute, Protiva had attempted to block the spin out of Tekmira (see RNAi News, 7/20/2006).
SR Pharma Changes Name, Pushes Back Drug Development
SR Pharma said last week that its shareholders have approved the renaming of the company to Silence Therapeutics to reflect the firm’s focus on RNAi therapeutics.
The company had announced its plan to do so last month (see RNAi News, 4/5/2007).
SR Pharma also said that it has pushed back the clinical development timeline of its lead drug candidate, the siRNA-based cancer therapy Atu-027, to 2008. Previously, the company had projected phase I studies of the drug would begin in the second half of this year.
“In order to optimize the risk/benefit ratio in acutely ill patients we prefer to perform more pre-clinical testing before moving Atu-027 into patient trials next year,” Silence Chairman Iain Ross said in a statement.
Sigma-Aldrich Posts 12 Percent Rise in Q1 Revenue; Profit Increases 13 Percent
Sigma-Aldrich last week said its first-quarter revenue increased 12 percent as R&D spending rose 8 percent and net income increased 13 percent.
Total revenues for the three months ended March 31 rose to $495.9 million from $443.1 million year over year.
R&D spending increased to $14.1 million from $13 million year over year.
The company said profit increased to $74.9 million from $66.5 million in the year-ago period.
Sigma-Aldrich said it had around $173 million in cash and equivalents as of March 31.